Shield Therapeutics' ST10 delivers robust results in AEGIS Ph III program

Independent UK pharma firm Shield Therapeutics has announces strongly positive top-line data from the pivotal Phase III program of ST10 for the treatment of iron deficiency anemia (IDA) in inflammatory bowel disease (IBD).

ST10, a novel orally-dosed form of ferric iron, delivered a mean improvement in haemoglobin levels of 2.3g/dL (p <0.0001), clearly meeting the primary endpoint of haemoglobin change after 12 weeks’ treatment compared to placebo. More than 65% of treated subjects experienced normalized hemoglobin levels by week 12 and ST10 also rapidly delivered significant improvements in haemoglobin at 4 weeks (1.1g/dL, p <0.0001) and 8 weeks (1.8g/dL, p <0.0001) of therapy. From a safety perspective, ST10 did not adversely affect IBD symptoms in treated subjects and was well tolerated for the duration of exposure.

The two AEGIS protocols recruited 128 patients with anemia secondary to either Crohn’s disease or ulcerative colitis who had previously failed therapy with oral ferrous products due to intolerance and/or inadequate therapeutic benefit. Patients were recruited from expert centres in Austria, Germany, Hungary and the UK and were randomized (1:1) to receive ST10 or a matched placebo capsule. Other iron therapies were not permitted during the study. Adverse events recorded during the study were mainly gastrointestinal in nature and occurred in the ST10-treated arm with placebo-like frequency (38% of ST10-treated subjects and 40% of placebo-treated subjects).